ASTM F2258-05

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F2258–05
Standard Test Method for
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Strength Properties of Tissue Adhesives in Tension
This standard is issued under the fixed designation F2258; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.1 tissue adhesive—for the purposes of this test method,
tissue adhesive is defined as a compound or system intended
1.1 This test method is intended to provide a means for
for use in closing wounds (surgical or traumatic) or for sealing
comparison of the adhesive strengths of tissue adhesives
against leakage of body fluids.
intended for use as surgical adhesives or sealants, or both, on
3.2.2 tissue sealant—a surface coating with adequate adhe-
softtissue.Withtheappropriatechoiceofsubstrate,itmayalso
sive strength to prevent leakage of body fluids.
be used for purposes of quality control in the manufacture of
tissue adhesive based medical devices.
4. Significance and Use
1.2 The values stated in SI units are to be regarded as the
4.1 The utility, range, and efficacy of adhesives in clinical
standard.
medicine are well documented in the literature. Whether being
1.3 This standard does not purport to address all of the
used as an adhesive, hemostatic, sealant, or carrier for drugs or
safety concerns, if any, associated with its use. It is the
growth factors, or both, the scope of adhesive use in clinical
responsibility of the user of this standard to establish appro-
medicine continues to expand. There are several factors which
priate safety and health practices and determine the applica-
arevitaltothesuccessandefficacyofamedicaltissueadhesive
bility of regulatory limitations prior to use.
including, (1) adequate tissue bonding strength, (2) tissue
2. Referenced Documents compatibility, (3) acceptable biodegradable properties when
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the adhesive is used internally, (4) availability, (5) ease of
2.1 ASTM Standards:
application, and (6) cost.
D907 Terminology of Adhesives
4.2 Medical adhesives are currently used for a variety of
E4 Practices for Force Verification of Testing Machines
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applications and tissue types.Applications range from fixation
2.2 American Association of Tissue Banks Standards:
of external tissues to internal application for use with either
Standards for Tissue Banking
similar or dissimilar opposing surfaces.While the biological or
3. Terminology
chemical makeup, or both, of the adhesive may define its
characteristics, additional mechanical factors including adhe-
3.1 Definitions—Many terms in this test method are defined
sive volume or method of application, or both, may also
in Terminology D907.
contribute significantly toward the performance of the adhe-
3.2 Definitions:
sive. In an effort to fairly and adequately quantify adhesive
bonding strength for medical adhesives, it is important to
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
develop a consistent, reproducible testing standard for evalua-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
tive and comparative purposes. Due to the fact that the
F04.15 on Material Test Methods.
adhesives will be used on or in living tissues, a readily
Current edition approved Mar. 1, 2005. Published March 2005. Originally
approved in 2003. Last previous edition approved in 2003 as F2258 – 03. DOI:
available biological testing surface is preferred.
10.1520/F2258-05.
4.3 The data generated from a standardized testing method
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For referenced ASTM standards, visit the ASTM website, www.astm.org, or
on biologic tissue may vary from that found in vivo, however,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on testing results should offer valuable information on the poten-
the ASTM website.
tial bonding capacity and for the preparation of subsequent in
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Available from the American Association of Tissue Banks (AATB), 1350
vivo experiments.
Beverly Rd., Suite 220-A, McLean, VA 22101.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
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F2258–05
4.4 The complexity and variety of individual applications due to ease of use and the potential for more consistent
for tissue adhesive devices, even within a single indicated use properties.Itshouldbethawedaccordingtothemanufacturer’s
(surgical procedure), is such that the results of a tensile test are instructions prior to use. Unused graft may be kept at 2 to 8°C
not suitable for determining allowable design stre
...